hepatic

When Volume Matters, Immunoassay Systems Deliver

...tus, endocrine functions, fertility and pregnancy, hepatic and renal function, oncology, infectious disease, and many others. More than a dozen manufacturers produce these systems worldwide and their features vary widely, but all offer reliable, workhorse devices that form a backbone for clinical lab product...

Immunoassay Systems - Your Laboratory Workhorse

...tus, endocrine functions, fertility and pregnancy, hepatic and renal function, oncology, infectious disease, and many others. More than a dozen manufacturers produce these systems worldwide and their features vary widely, but all offer reliable, workhorse devices that form a backbone for clinical lab produc...

MediGene Announces Cancer-Fighting Virus Shows Promise in Early Clinical Trial

...erimdata from a Phase I/II trial testing NV1020 on hepatic metastasesfrom CRC are encouraging. Methods: NV1020 was administered as 4weekly intra-arterial infusions at up to 1x10e8 pfu to patients whohad failed first-line therapy. Viral therapy was followed by twocycles of second-line chemotherapy using FDA-a...

New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV

...use of PREZISTA inpatients with varying degrees of hepatic impairment; therefore,specific dosage recommendations cannot be made. Redistribution and/or accumulation of body fat have beenobserved in patients receiving ARV therapy. The causalrelationship, mechanism, and long- term consequences of theseevents h...

Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial

...d subjectsreceiving Biaxin(R), consistent with the hepatic and cardiac sideeffect profile reported in cethromycin's previous clinicaltrials. Cethromycin is not approved as a treatment for CAP, and datafrom this analysis have not been reviewed by the FDA. Update to Trial CL-05 Timeline The Company also upd...

Aspreva and Roche Announce Preliminary Results for Phase III Study Evaluating CellCept in Lupus Nephritis

...ressive therapy and managementof renal, cardiac or hepatic transplant patients should useCellCept. Patients receiving the drug should be managed infacilities equipped and staffed with adequate laboratory andsupportive medical resources. The physician responsible formaintenance therapy should have complete in...

An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes

...stment isneeded for patients with mild to moderate hepatic insufficiency orin patients with mild renal insuff...ion from pancreatic alpha cells, leading toreduced hepatic glucose production. By increasing and prolongingactive incretin levels, JANUVIA increases insulin re...

Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes

...stment isneeded for patients with mild to moderate hepatic insufficiency orin patients with mild renal insuff...ion from pancreatic alpha cells, leading toreduced hepatic glucose production. By increasing and prolongingactive incretin levels, JANUVIA increases insulin re...

New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir

...) may need to beadjusted in patients with renal or hepatic impairment. *Whether the observed differences in weight represent truedifferences in the effects of Levemir(R) and other therapies is notknown, since these trials were not blinded and the protocols (e.g.,diet and exercise instructions and monitoring...

Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial

...dsubjects receiving Biaxin(R), consistent with the hepatic andcardiac side effect profile reported in cethromycin's previousclinical trials. Cethromycin is not approved as a treatment for CAP, and datafrom this analysis have not been reviewed by the FDA. No furtherdetails of the clinical study will be avail...

Three Studies Suggest Abbott's Humira (adalimumab) May Improve Work Productivity in Patients with Rheumatoid Arthritis

...inal pain, stomatitis and mouthulceration, nausea, hepatic enzymes increased, rash, dermatitis andeczema, pruritus, hair loss, musculoskeletal pain, pyrexia, fatigue(including asthenia and malaise). About HUMIRA HUMIRA is the only fully human monoclonal antibody approved forthe treatment of rheumatoid arth...

Study Demonstrated Rozerem (ramelteon) Does Not Affect Middle-of-the-Night Balance in Older Adults with Insomnia

...tivity toany components of the formulation, severe hepatic impairment, or incombination with fluvoxamine. Failure of insomnia to remit after areasonable period of time should be medically evaluated, as thismay be the result of an unrecognized underlying medical disorder.Hypnotics should be administered with ...

Clinical Data Reported on Vidaza in Hematologic Malignancies and Advanced Solid Tumors

...or mannitol and in patients withadvanced malignant hepatic tumors. In clinical studies, the most commonly oc...ly hepatotoxic in patients withsevere pre-existing hepatic impairment, caution is needed inpatients with liver disease. In addition, azacitidine and itsmetabol...

Caelyx Delays Time to Disease Progression as Maintenance Therapy in Patients with Metastatic Breast Cancer

...ian age of 57, and had adequatebone marrow, renal, hepatic and cardiac function. These patientshad experience... Dosage should be reduced in patientswith impaired hepatic function. Accidental substitution of DOXILfor doxorubicin HCl has resulted in severe side effects. D...

Lilly Studies Try to Shed Light on Impact of Race on Lung Cancer Treatment

... Administration of GEMZAR may exacerbateunderlying hepatic insufficiency. The optimum regimen for safe administration of GEMZAR withtherapeutic doses of radiation has not yet been determined in alltumor types. GEMZAR has radiosensitizing activity and radiationrecall reactions have been reported. It is not ...

In New Study, Duloxetine Was Equally Effective, Regardless of Switch Method, in Reducing Painful Symptoms in Ssri Non- or Partial-responders with Depression

...allergic to it,who have liver disease resulting in hepatic impairment, who aretaking a monoamine oxidase inhibitor (MAOI), fluvoxamine,ciprofloxacin or enoxacine or who have severe kidney disease. Theinitiation of treatment with duloxetine also is contraindicated inpatients with uncontrolled hypertension tha...

New Study Suggests no Significant Impairment in Middle-of-the-Night Balance, Mobility or Memory in Older Adults Using Ramelteon

...tivityto any components of the formulation, severe hepatic impairment, orin combination with fluvoxamine. Failure of insomnia to remit aftera reasonable period of time should be medically evaluated, as thismay be the result of an unrecognized underlying medical disorder.Hypnotics should be administered with ...

Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril

...irment (creatinineclearance <40 mL/min), or in hepatic dysfunction. In patientswith possible depletion of intravascular volume (e.g., patients ondiuretics, particularly with impaired renal function), BENICARshould be initiated under close medical supervision andconsideration given to use of a lower start...

King Pharmaceuticals Reports Efficacy of Altace 20mg And Efficacy of a Combination of Altace 20mg And Hydrochlorothiazide 25mg For 24-hour Blood Pressure Control

...th caution inpatients with renal disease, impaired hepatic function orprogressive liver disease, diabetes, gout or lupus erythematosus.Common side effects include dizziness, light-headedness, low bloodpressure, dehydration and stomach irritation. About King Pharmaceuticals King, headquartered in Bristol, T...

Early Results of the CellCept Spare the Nephron Study Examine Kidney Function

...ressive therapy and managementof renal, cardiac or hepatic transplant patients should useCellCept. Patients receiving the drug should be managed infacilities equipped and staffed with adequate laboratory andsupportive medical resources. The physician responsible formaintenance therapy should have complete in...

Abraxis BioScience Presents Pre-Clinical Findings That Support Role of SPARC Expression in Cancer and the Role of the Nanoparticle Albumin Bound (nab) Technology Platform in Targeting the Pathway

...lar/visualdisturbances, fluid retention, alopecia, hepatic dysfunction,mucositis, and renal dysfunction. For the full prescribinginformation for ABRAXANE(R), please visit www.abraxane.com. ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE ismarketed in the United States under a co-promotion agreem...

Abraxis BioScience Presents Data from Pre-Clinical Study That Provide Evidence for Chemotherapy-Induced Angiogenesis and Rationale for Combining nab-Paclitaxel (Abraxane) with Anti-Angiogenic Agents to Increase Tumor Response

...lar/visualdisturbances, fluid retention, alopecia, hepatic dysfunction,mucositis, and renal dysfunction. For the full prescribinginformation for ABRAXANE(R), please visit www.abraxane.com. ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE ismarketed in the United States under a co-promotion agreem...

New One-Year Pharmacoeconomic Study Shows Avonex is Cost-Effective Relative to Other Interferon Therapies for Multiple Sclerosis

...red. Patients should also bemonitored for signs of hepatic injury. Routine periodic bloodchemistry and hematology tests are recommended during treatmentwith AVONEX. Rare cases of anaphylaxis have been reported. Pleasesee complete prescribing information available atwww.AVONEX.com. About Biogen Idec Biogen ...

Positive Results Prompt US National Cancer Institute to Make Glivec Available to Patients in Post-Surgical GIST Study

... failure, thrombosis/embolism,ileus, pancreatitis, hepatic failure, exfoliative dermatitis,angioedema, Stevens-Johnson syndrome, renal failure, fluidretention, edema (including brain, eye, pericardium, abdomen andlung), hemorrhage (including brain, eye, kidney andgastrointestinal tract), diverticulitis, gast...

Positive Results Prompt US National Cancer Institute to Make Gleevec Available To Patients in Post-Surgical Gist Study

... at both dose levels studied Patients with severe hepatic impairment should be treated at astarting dose of 300 mg/day and should be closely monitored Gleevec is metabolized by the CYP3A4 isoenzyme and is aninhibitor of CYP3A4, CYP2D6, and CYP2C9. Dosage of Gleevec shouldincrease by at least 50%, and clini...

In New Study, Duloxetine Reduced Non-specific Pain and Emotional Symptoms Associated with Depression

...allergic toit, who have liver disease resulting in hepatic impairment, who aretaking a monoamine oxidase inhibitor (MAOI), fluvoxamine,ciprofloxacin or enoxacine or who have severe kidney disease. Theinitiation of treatment with duloxetine also is contraindicated inpatients with uncontrolled hypertension tha...